Radiofrquency Ablation Combined With Cytokine-induced Kil... | NCT02419677

Studies
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases

NCT02419677

Sponsor

The First People's Hospital of Changzhou

Status

Completed

Last Update Posted

Apr 17, 2015Estimated

Enrollment

60Actual

Phase

Phase 2Phase 3

Conditions

Colorectal Cancer

Interventions

Radiofrequency ablation
Cytokine-induced killer cells

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 9, 2015

First Submission Date that Met QC Criteria

Apr 14, 2015

First Posted Date

Apr 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2015

Last Update Posted Date

Apr 17, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liangrong Shi, Director of Science and Education Division, The First People's Hospital of ChangzhouPrincipal Investigator

Lead Sponsor

The First People's Hospital of ChangzhouOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with colorectal cancer liver metastases (CRCLM).

Detailed Description

The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with resectable CRCLM.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RFA alone	Other	Patients undergo radiofrequency ablation alone.	Procedure: Radiofrequency ablation
RFA+CIK	Experimental	Autologous cytokine-induced killer cells were transfer via venous one week after RFA.	Procedure: Radiofrequency ablation Biological: Cytokine-induced killer cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency ablation	Procedure	Radiofrequency ablation is performed percutaneously under CT/US guidance.	RFA alone RFA+CIK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence-free survival	Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.	One year

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Adverse events related to RFA and CIK treatments.	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically confirmed adenocarcinoma
Primary lesions (colorectal cancer) are resected
Must have undergone prior complete resection of the primary tumor; liver metastases
Must be resectable or accessible for radiofrequency ablation (Five or less lung metastases measuring 5 cm or smaller).
Serum bilirubin level of 2.0 mg/dl or less.
Performance status of 0 or 1.
Expected survival of 1 year or more.
Informed consent from the patient.

Exclusion Criteria:

With extrahepatic metastases
With other neoplastic disease that is measurable or being treated other than colorectal cancer.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Changping Wu, M.D.	The First People's Hospital of Changzhou	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First People's Hospital of Changzhou		Changzhou	Jiangsu	213003	China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided